Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain

Investigation of the Effectiveness of Electrotherapy Treatment for the Spine in Individuals with Chronic Low Back Pain

This study investigates the effectiveness of a specific electrotherapy treatment for individuals with chronic non-specific low back pain. The participants, who had low back pain for more than three months, were divided into two groups: a treatment group and a waitlist control group. The treatment group received electrotherapy using the StimaWELL 120MTRS system, which provided electrical stimulation and heat therapy to the entire spine over four weeks. The study assessed various outcomes, including pain levels, disability, and quality of life, before and after the intervention.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: The StimaWELL 120MTRS system

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-65 years old,
• LBP for more than three months,
• Pain of 3 or more according to the Numeric Pain Scale
• being literate

Exclusion Criteria:

• having a pacemaker,
• body mass index greater than 30,
• pathologies of the cervical or lumbar region,
• cervical radiculopathy, thoracic outlet syndrome, malignant conditions,
• systemic diseases, such as neurological, psychological, cardiovascular or rheumatologic conditions, loss of function due to these diseases,
• history of surgery on the spine or upper extremities,
• acute infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: StimaWell; Participants in the StimaWELL group had previously received electrotherapy treatment for the entire spine for 4 weeks, 2 days a week. Before the treatment, participants were informed about their medical condition and the planned treatment. The StimaWELL 120MTRS system (StimaWELL® 120MTRS; Schwa-medico, Wetzlarer Straße 41-43, 35630 Ehringshausen, Germany) was used for the treatment and a stimulation mat was used to apply electrical stimulation along the entire back. The 12 channels of the mat provided different current intensities to different areas and the system offered programs tailored to various therapeutic goals.	Device: The StimaWELL 120MTRS system; A standardized current (dynamic deep wave stimulation) was applied to all patients. Additionally, the mat, which reached a temperature of 40°C, provided heat therapy with electrical stimulation
No Intervention: Waitlist; Patients presenting to the clinic for treatment and waiting without intervention in the waitlist group after routine evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing Scale	Participants' pain catastrophizing levels were measured using the Pain Catastrophizing Scale (PCS). The total score of the PCS is 52, with higher scores indicating higher levels of catastrophizing behavior.	Before and after 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Scale	Pain intensity during activity, at rest and at night was assessed with the Numeric Pain Scale. It was graded with "0" representing "no pain" and "10" representing "the worst pain imaginable".	Before and after 4 weeks of treatment
Oswestry Disability Index	Disability level was assessed with the Oswestry Disability Index. The scale consists of 10 items, each ranging from 0 to 5, with a total score of 100. Higher scores indicate higher levels of disability.	Before and after 4 weeks of treatment
Nottingham Health Profile	The Nottingham Health Profile was used to assess participants' health-related quality of life. The first part of the NHP contains 38 items covering six domains: pain, physical activity, emotional reactions, energy, social isolation and sleep. Each domain is scored from 0 to 100 and the total score is the sum of these domain scores. Only the first part of the NHP was used for this study	Before and after 4 weeks of treatment

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Özlem Ülger, professor, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: chronic low back pain; electrotherapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HUSpine017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No